Specialty Pharmaceuticals Care Management in an Integrated Health Care Delivery System with Electronic Health Records

The specialty pharmaceuticals market is expanding more rapidly than the traditional pharmaceuticals market. Specialty pharmacy operations have evolved to deliver selected medications and associated clinical services. The growing role of specialty drugs requires new approaches to managing the use of these drugs. The focus, expectations, and emphasis in specialty drug management in an integrated health care delivery system such as Kaiser Permanente (KP) can vary as compared with more conventional health care systems. The KP Specialty Pharmacy (KP-SP) serves KP members across the United States. This descriptive account addresses the impetus for specialty drug management within KP, the use of tools such as an electronic health record (EHR) system and process management software, the KP-SP approach for specialty pharmacy services, and the emphasis on quality measurement of services provided. Kaiser Permanente’s integrated system enables KP-SP pharmacists to coordinate the provision of specialty drugs while monitoring laboratory values, physician visits, and most other relevant elements of the patient’s therapy. Process management software facilitates the counseling of patients, promotion of adherence, and interventions to resolve clinical, logistic, or pharmacy benefit issues. The integrated EHR affords KP-SP pharmacists advantages for care management that should become available to more health care systems with broadened adoption of EHRs. The KP-SP experience may help to establish models for clinical pharmacy services as health care systems and information systems become more integrated.

• Specialty pharmaceuticals are a growing segment of medication use. • Specialty pharmacies (SPs) have evolved to meet certain needs for specialty drugs, including assurance of reimbursement, promotion of adherence, specialty drug dispensing, and compliance with Risk Evaluation and Mitigation Strategy (REMS) requirements.

What is already known about this subject
• Kaiser Permanente Specialty Pharmacy (KP-SP) is an example of an internal SP in an integrated health care delivery service with an electronic health record (EHR) system. • EHR access to the complete patient record plus connectivity with other providers and patients can be used to optimize clinical pharmacy services for specialty drugs. • Drug-specific standard operating procedures plus softwareassisted workflow queues can be used to guide and coordinate multiple aspects of pharmacy services for specialty pharmaceuticals and to provide efficient care.

What this study adds
C O M M E N TA R Y S pecialty pharmacy (SP) delivery systems have grown in response to the increasing number and importance of specialty pharmaceuticals. Specialty drugs can offer new options for therapy, sometimes in previously untreated diseases. In the United States, specialty drugs have been reported to amount to 17% of total 2011 revenues in the pharmaceutical industry. 1 Any such estimate depends upon how specialty drugs are defined. At Kaiser Permanente (KP), specialty pharmaceuticals have been defined as drugs that bear a high cost per patient (usually greater than $600 per month), require unusual or resource-intensive dispensing or handling processes, require focused clinical management, or present a risk for outsourcing of dispensing.
SPs, as compared with traditional outpatient pharmacies, offer solutions to resource challenges or added processing steps for many outpatient specialty drugs. Drivers for the evolution of SP businesses have included high cost for drug inventory, a need to ensure reimbursement, an opportunity to promote medication adherence, and the need to implement safety requirements defined by U.S. Food and Drug Administration (FDA)-approved Risk Evaluation and Mitigation Strategies (REMS). 2 Consolidation within the resulting SP businesses has led to large national operations serving nationwide patient populations. 1 There remains, however, a vital role for smaller or more focused SP services. This may include organizationspecific SP operations, disease-management SPs, regional SPs, or other models that meet specific needs or provide defined levels of care and service.
KP is an integrated health care delivery system with an electronic health record system. KP consists of the following: • health plan, Kaiser Foundation Health Plan, Inc.
• hospital system, Kaiser Foundation Hospitals • medical group, Permanente Medical Groups Thus, KP is the insurer and the provider. KP also operates its own local pharmacies, which fill over 70 million prescriptions per year. 3,4 A national specialty pharmacy (KP-SP) provides dispensing and clinical services for a number of specialty drugs.
Drivers for SP handling of specialty drugs within KP are not always parallel with drivers outside of KP. Promotion of medication regimen adherence and assurance of compliance with REMS requirements are imperatives for KP-SP, just as they are for other SPs. With KP, however, a patient's drug insurance coverage is known immediately by prescribers and tions for existing specialty drugs have also become a significant factor. 12,13 An actual count depends upon the definition of specialty pharmaceuticals. In Table 1, we have applied the KP definition and have calculated the number of approvals for new molecular entities (NMEs) that might be considered specialty drugs, as well as the number of new indications for existing specialty drugs. In addition, using information on current filings with the FDA reported in Pharmaceutical Approvals Monthly, we have estimated the number of specialty drug applications already filed with the FDA with potential for approval in 2013. 14 From these trends and predictions, we may assume that a shift towards specialty drugs is well underway and can be expected to continue.

■■ Stimuli for Creation and Expansion of the KP-SP
The KP-SP service started in 2006 to provide KP members in all KP regions with selected specialty pharmaceuticals. Several drivers have entered into the creation and expansion of KP-SP, including those discussed below.

KP Pharmacy Service Versus Outsourced Dispensing
Manufacturer-driven limited distribution schemes for new specialty drugs have been encountered by KP with increasing frequency. Therefore, an opportunity existed for improvement in pharmacy services through establishment of an SP. As compared with outsourced dispensing, internal KP-SP dispensing and clinical services allow pharmacists to directly view and assess lab results, ensure test compliance, review physician notes, align counseling with treatment plans, provide drugversus-drug interaction screening against the patient's complete medication profile, avoid wastage by coordinating refills with physician appointments, and problem solve for benefits issues or financial assistance opportunities. These abilities pharmacists (displayed online during ordering or dispensing), removing extra steps for confirmation of reimbursement. In addition, ongoing coordination of pharmacy operations with the medical group leads to guidelines, disease-management plans, or treatment initiatives that may be implemented through SP clinical services. This helps to define and focus clinical imperatives for safe, effective, and efficient use of specialty drugs. For example, agreement on the importance of monitoring renal function for patients receiving a given drug becomes the basis for clinical intervention by a pharmacist to ensure that appropriate laboratory tests are ordered and completed.
Refinement of disease-management models increasingly will be necessary to ensure the most effective use of health care resources. Recent articles regarding rheumatoid arthritis and multiple sclerosis treatment, for example, have highlighted paradigm shifts in disease management and the need for improvement in process metrics and outcomes metrics. 5,6 Such metrics will be critical to multidisciplinary disease-management models, bringing physicians, pharmacists, and other providers together in an organized treatment plan with established objectives. Clinical services from SP pharmacists can be a core component. The use of an electronic health record (EHR) coupled with ambulatory care clinical management can grow pharmacy service capabilities and improve the effectiveness of disease-management models.
This descriptive report discusses KP-SP's approach to the challenges of specialty drugs within KP's integrated delivery system, explaining the purpose for development of a specialty pharmacy, the tools employed, the operational approach, and the results of services.

■■ The Importance of the Specialty Pharmaceuticals Market
Growth of the specialty pharmaceuticals market is evident in current drug approval trends and has been projected in published analyses. Express Scripts' annual "Drug Trend Report" shows that per-member-per-year (PMPY) pharmacy benefit spending on all pharmaceuticals grew at 3.6%, 2.7%, and 2.7% in 2010, 2011, and 2012, respectively. [7][8][9] For the same years, the specialty pharmaceutical segment growth rate was 19.6%, 17.1%, and 18.4%. [7][8][9] Further, it is reported that almost 70% of total specialty drug spending involved 4 indication groups: inflammatory conditions, multiple sclerosis, cancer, and human immunodeficiency virus. 8 In the report "2011 Drug Trend Insights," Prime Therapeutics stated that specialty drugs account for less than 1% of all prescriptions in the United States, but also account for approximately 20% of total U.S. spending on prescription drugs, which they reported to be $307 billion in 2010. 10 In 2008, Kober projected that specialty drugs will reach 44% of total pharmacy spending by the year 2030. 11 Review of FDA approval postings shows that new indica-  may lead to enhanced clinical oversight and cost-efficiencies for specialty drugs that may cost several thousand dollars per month of treatment. Service improvements are also possible for prescription turnaround times, adherence promotion, and continuity of care for members transitioned between hospital and home.

Increased SP Market
As previously discussed, the increasing rate of approvals for new specialty drugs, growth of new indications for existing specialty drugs, and increased usage and costs for specialty drugs were among other drivers for establishment of an internal SP. [7][8][9][10][11][12][13][14] Existing structures and tools for drug usage management are a mainstay for provision of affordable, quality care with KP. Physicians, pharmacists, and others work together to develop treatment initiatives, guidelines, protocols, or diseasemanagement planning. An SP becomes a new significant opportunity for application of these various tools in the use of specialty drugs. The importance of the SP grows with the increasing number of specialty drugs on the market.

New Drugs with Biomarkers
The FDA has approved several new drugs with biomarkers included in their indications, such as ivacaftor (Kalydeco), or with companion diagnostics, such as crizotinib (Xalkori) and vemurafenib (Zelboraf). 12,[15][16][17] The FDA has also established a framework (draft guidance) for the codevelopment and parallel approval of companion diagnostics as exemplified by crizotinib and vemurafenib. [18][19][20] Pharmacists in the SP environment can assist in the appropriate use of these agents by reviewing the indications and diagnostic tests performed for each patient prior to dispensing the first prescription. Drug and medical record reviews are performed, and a telephone interview with the patient is conducted to provide education regarding use of the specialty drug and to gather further health care history specifics. If needed, the pharmacist communicates with the prescriber to determine if testing should be ordered. This SP process can assist in assuring that use of a specialty drug is directed to patients most likely to benefit from the drug.

REMS
REMS may include various requirements that are best facilitated by SP management of a drug. Elements To Assure Safe Use (ETASU) as a part of a REMS may begin to define safety monitoring, but further safety monitoring may be added as needed. ETASU may include prescriber and patient registries, monitoring for labs, requirements for pregnancy testing, or other specified safety measures. 2,21 Such responsibilities may add steps to traditional pharmacy workflow, which follows a linear design, minimizing branches in the workflow. With an internal SP, these added steps can be handled with process management software, which includes work queues and electronic reminders. The pharmacist has access to the EHR and lab results, enabling direct monitoring of critical indicators.

■■ Tools Connectivity in an Integrated Health Care Delivery System
KP has been functionally integrated from its inception, with the health plan, providers, hospitals, medical office building, and pharmacies all working together. Now, KP is also electronically integrated through KP HealthConnect, an EHR system. 22,23 Members can access KP online to have prescriptions filled, contact their doctors, and learn about test results or be guided to therapy. Within 5 years after implementation of KP HealthConnect, a large portion of KP members were utilizing online health management features, creating appointment and prescription refill requests via online services, corresponding with their health care providers via email, and viewing laboratory test results online. This growing connectivity of members signals an integration of patient involvement with the health care delivery system.

Ambulatory Care Staffing
Pharmacy staff is a key ingredient in the quality of service in any pharmacy operation. At KP-SP, all pharmacists are ambulatory care pharmacists qualified by prior clinical pharmacy training (completion of either a residency or 3 years of equivalent clinical experience) to deliver clinical case management services. The duties of these pharmacists include the dissemination and application of clinical and cost-effectiveness information about specialty drugs through close interaction with physicians and other health care providers in the drug therapy process. In addition, the KP-SP pharmacists conduct patient medication histories, counsel patients, identify medicationrelated problems, and synthesize treatment plans for patients in coordination with their physicians. Through these activities, pharmacists may make or contribute to decisions regarding drug selection, changes in dosage or route of administration, drug interactions, or basic drug supply logistics.
One-on-one communication with patients is another critical role played by the pharmacists to achieve effective delivery of specialty care clinical services. The pharmacists interview patients for medication history and use the same session to educate patients and their caregivers. This supplement to patient education often fills gaps in patient understanding, thereby preventing problems with drug regimen adherence. In addition, pharmacists can uncover previously unknown medical history information or special circumstances that may alter therapy decisions (e.g., previously unreported conditions in which a certain specialty pharmaceutical might require dosage alterations or might be contraindicated), medication use not included in the patient's prescription history, or a patient's misunderstanding of prescription instructions. Technicians at KP-SP are also trained in support of ambulatory care clinical services, SP procedures, logistics, and benefits issues.

Scope
Purpose Example: "This process will be used to ensure the proper administration of and compliance with the FDA-approved REMS for <Drug X> with the Kaiser Permanente Specialty Pharmacy…." Example: "To describe the proper procedures for prescription intake, REMS Elements To Assure Safe Use, added safety monitoring, and efficient delivery of clinical and dispensing services for <Drug X>…."

KP-SP Contact Information and Business Hours
Definitions • Phone/Fax/TTY numbers • E-mail address • Business hours Example: For "PIMS," "SPIMS," and other acronyms and system names used in the SOP.

REMS Overview
REMS Schematic (simplified example; actual schematic is more complex) • Medication guide • Communication plan participation • Elements to ensure safe use • Implementation system • Assessment-possible participation

SP Processes Step-By-Step [Queue-Based Process]
REMS Contact Information Example: 1. Review incoming Rx* or refill requirements* 2. Check labs/tests, EHR notes, MD visits/notes, Rx profile, etc.* 3. Counsel patient/caregiver* and review benefits issues 4. Adverse event documentation requirements 5. Obtain confirmation number from REMS hub 6. Dispensing elements* 7. Documentation requirements* logistics, labels, filling, shipping 8. REMS data transmission requirements* 9. Perform drug accountability procedures * with detailed checklist(s); all steps documented Example: Call center numbers, online elements, locations for forms, etc.

REMS Data Requirement
Example: What information is required for call center; what data are transmitted electronically, PHI safeguards; inventory reporting requirements, etc.

Metrics
Clinical Monitoring Specifications Standards for measurement of processes, adherence, intermediary clinical indicators, or outcomes Labs, pregnancy testing, EKGs, etc.

References
Usage Management Criteria, Guidelines, or Initiatives Example: Internal (evidence reviews, formulary decisions, guidelines); external (critical FDA documents, manufacturer resources, REMS) Example: Guidelines defining safety monitoring; initiatives to review treatment alternatives; criteria for treatment review after a specified duration of therapy; etc.

SPIMS and SOPs
In addition to the integrated design of KP's health care delivery system and the presence of a comprehensive EHR, the following are 2 of the most powerful tools used by KP-SP: • Standard Operating Procedures (SOP). SOPs define elements and criteria for services delivered for specialty drugs managed by the SP. This may include REMS compliance, clinical monitoring, checking for pregnancy tests, patient education, guidelines coordination, adverse event reporting, or other elements that should be performed in a reliable and consistent manner (see Table 2).

• Specialty Pharmacy Information Management System (SPIMS).
SPIMS is an SP software addition to the Pharmacy Information Management System (PIMS). SPIMS is pro-   Table 3 for capabilities of SPIMS). SPIMS can be customized as needed for each specialty drug, enabling pharmacists to deliver consistent clinical case management services efficiently by utilizing "queues" and "role-based" approaches. When an SP staff member signs on to SPIMS, the workflow queues for that day (e.g., checking labs, counseling patients, final fill and shipping) are listed for a pharmacist or technician, depending on the role of the user who is signing onto the system.

■■ Operations KP-SP Operations and Models
As can be understood from the tools previously described, the routine operations at KP-SP involve many tasks. Workflow management is accomplished with queue-based software as a part of SPIMS. In addition, SPIMS allows for pharmacists to view and interact with all parts of the health care system. Table  4 lists some of the specialty drug management functions that can be performed in the internal SP model, with integrated delivery design, an EHR, and functional connectivity between patients and providers. Outsourcing to a non-KP SP may circumvent some of these functions, while KP-SP maximizes the opportunities that the integrated delivery system provides.
The following examples demonstrate capabilities of an internal SP: • Scenario A. A new drug has a REMS based on cardiotoxicity and QT interval prolongation observed in clinical trials.
The REMS requires education of prescribers plus provision of information to patients to make them aware of cardiotoxicity signs and symptoms. The KP internal SP, with the integrated system and EHR, can adopt further safeguards. SPIMS can be programmed with reminders and documentation to check electrolyte balance, to ensure that recommended periodic electrocardiograms are performed, and to monitor for addition of new medications that could also prolong the QT interval. • Scenario B. A drug requires monthly pregnancy testing.
The pharmacist with EHR access does not need to call the patient, prescriber, or a lab to affirm that the test has been performed and is negative because the tests are visible in the EHR for the internal SP staff. In addition, alerts prompt pharmacists to notify patients in advance that they need to have their tests done to avoid any gap in therapy.
KP-SP is currently a centralized SP, with all clinical and distributive pharmacy services conducted out of 1 location. A core strength of this service is the direct, personal communication with patients via telephone. In some treatment scenarios, however, pharmacists at local medical centers may already be providing clinical care for patients on a one-on-one basis in care clinics, oncology pharmacies, infectious disease services, or other ambulatory care service models.
The SP SOPs and SPIMS at KP can facilitate this face-to-face service through centralized/decentralized SP clinical services, a new model being considered for adoption at KP that would

SPIMS Function Description Work queues
• Security access is role-based (pharmacist or technician).
• Work queues are presented when staff signs onto SPIMS, listing necessary actions. • Queues guide pharmacists or technicians to make patient calls, review lab results, contact prescribers, or perform other activities in the multilinear workflow described in Figure 2. Laboratory links • SPIMS modules are designed to place preselected laboratory results (e.g., creatinine clearance calculations) on the pharmacist's working screen (as seen in Figure 3) with out-of-range results highlighted for attention. • This facilitates efficient clinical monitoring and provides alerts when results are out-of-range results. Monitoring checklists • SPIMS modules are designed in linkage with the standard operating procedure.
• Monitoring alerts notify pharmacists in advance that a test needs to be performed (e.g., pregnancy test).
• Monitoring requirements are listed and documented (by clicking a box). Systems alerts • Reminders appear at least 7 days prior to an expected refill, allowing reminders to patients of needed labs.
• System alerts also facilitate adherence counseling and decrease problems at the time of refills.
• Abnormal lab results are displayed in the Critical Lab Queue immediately. Refill anticipation • System alerts allow for planning of refill quantities.
• Refills are planned around physician office visits. A limited quantity of drug might be provided, with the pharmacist re-contacting the patient after the physician visit to discuss any medication therapy changes and avoiding waste. Counseling checklists • Each scheduled communication with a patient is supported by SPIMS scripting and checklists to guide and document the counseling discussions and REMS compliance. • Example: If a patient is receiving a drug with pregnancy risks, the counseling script (on screen, with sufficient detail) may include notes prompting the pharmacist to discuss relevant information (e.g., risk of serious birth defects, need for contraception, need for pregnancy tests, and when to contact the prescriber).

Specialty Pharmacy Information Management System (SPIMS) a
ized/centralized approach is implemented within KP, it will be possible to leverage the expertise of local clinical pharmacists who have training and experience in a specialty such as oncology or infectious disease.
Another component of the internal SP in the KP integrated system is oversight for non-outpatient medication use. In selected cases of clinic-administered or infused specialty drugs, the SP ensures that REMS requirements are met or that necessary prescriber training has been conducted. This occurs by involvement in the ordering process. Specified specialty be consistent with recommendations published by a National Comprehensive Cancer Network (NCCN) task force on SP. 24 For example, an oncology pharmacist at the KP medical center level may deliver clinical services, review charts, interact with patients, monitor labs, and evaluate and promote adherence by way of patient counseling, clinical functions already delivered at the local level in many medical centers. Given the integrated system and EHR within KP, centralized KP-SP personnel could then provide their centralized services for benefits or financial issues, logistics, filling, and shipping. If this type of decentral- • Pharmacist performs follow-through for inpatient and outpatient supply. REMS compliance for outpatient drugs • KP-SP meets all REMS requirements, aided by direct access to labs/tests/progress-note, SPIMS, automated checks and alerts. • KP-SP has ability to exceed REMS requirements (e.g., for a drug with cardiotoxicity issues, as appropriate, KP-SP can monitor for routine EKG completion, electrolyte balance, and new drugs that may prolong QT interval). REMS compliance for clinic-administered or infused specialty drugs • KP-SP provides centralized oversight for REMS compliance-enrollments, completion of infusion documentation, inventory tracking, etc.-and serves as a hub, authorizing fulfillment of drug orders only when requirements are met. Prescription filling workflow • Efficient queue-based, multilinear workflow management facilitates clinical and distributive services starting immediately after prescription order entry • All service components proceed in parallel, coordinated by SPIMS work queues and alerts to the KP-SP staff. Coordination with KP organizational goals • KP-SP linkage with Drug Information Services and with Pharmacy and Therapeutics Committee processes, Formulary, and Guidelines allows proactive interaction with prescribers in support of KP care management goals • KP-SP SOPs and SPIMS can be leveraged to allow service models with local clinical pharmacy service and centralized oversight and fill.  Clinical Service Capabilities for Integrated System with EHR a drugs are flagged so that an order alerts the internal SP. The SP staff then checks appropriate prescriber registries or seeks verification of compliance with REMS requirements (e.g., completion of prescriber-patient acknowledgement forms signifying that a risk-benefit discussion has occurred to provide safety information to a patient). This compliance assurance function is available in a centralized format only because the internal SP exists and has the necessary expertise and systems.

Linear Versus Multilinear Prescription Workflow
Traditional prescription workflow is designed to proceed in a linear manner whenever possible, as represented in Figure 1. Efficiency, especially in high-volume dispensing, depends upon limiting the number of prescriptions falling out of the linear flow, as this may create extra steps. Delays associated with order clarification, with obtaining a medication, or with obtaining REMS dispensing authorization are examples of aberrations in the linear workflow. Many specialty drugs dispensed through SPs require some step or steps that will halt workflow or will "branch off" from other steps in the workflow. Processing of a prescription may be halted while a patient has blood tests performed or while a patient is contacted for delivery logistics. Steps may be parallel and interdependent, such as those represented in Figure 2. SPIMS helps to manage this multilinear process with queue-based software that keeps track of all steps and branches and provides reminders and coordination of the various workflow elements.

Promotion of Adherence
The KP integrated system, the EHR, and KP-SP clinical case management services create an optimal scenario for promotion of compliance with medication regimens. All SPs have access to the last fill-date and can query patients about medication still in their possession. SPIMS adds some tools that keep adherence counseling on track, including the following: • System prompts. SPIMS notifies the pharmacist at least 7 days in advance of the next expected refill. In addition to clinical review and laboratory tests review (as seen in Figure 3) at this point, an interactive preconsultation screen in SPIMS (as seen in Figure 4) assists the pharmacist in logistics planning and assessment of adherence. • Counseling patients. All counseling is documented through SPIMS. Following system prompts, the pharmacist contacts the patient and asks for a count of doses still in the patient's possession to assess apparent regimen adherence. The pharmacist conducts a conversation to discover possible reasons for adherence problems and to seek solutions fortified by patient involvement and agreement. • Call-back reminders. Work queues in SPIMS allow for efficient call-backs to patients as needed (e.g., after laboratory results or physician office visits). When adherence problems are identified before or during a call-back, proposed solutions can be reinforced during the call.

Quality Metrics
Quality measurements are routinely conducted at KP-SP through frequent audits by third parties, internal metrics and audits, and surveys of members receiving KP services.
External audits. The most common reason for external audits is REMS. Under REMS programs, third-party auditors examine various aspects of the internal SP service. External auditors have verified performance quality in REMS audits where KP-SP has routinely achieved 99% to 100% compliance scores at first inspection in those audits that report a percentage of compliance. KP-SP has also satisfied any audits where results are reported in qualitative terms, such as whether requirements have been met. 25 Externally established metrics for turnaround time on new prescriptions (e.g., a goal of 72 hours from prescriber order to patient receipt of the target drug) have shown that KP-SP meets goal for more than 75% of new prescriptions. 25 Performance in this metric is high because the integrated nature of the KP system removes many of the potential reasons for turnaround delays, such as verification of coverage. Other drug-specific operational metrics have found average days to first fill to be within predefined goals (e.g., 1.2 days from physician order) and have shown pregnancy test criteria being met (100%, including about 5% physician-approved exclusions) for females of reproductive potential receiving specific drugs with safety issues related to pregnancy. 25 Prescriber

Multilinear Workflow in Specialty Pharmaceutical Prescription and Care Management Process
The drug in this example has a REMS program. Specialty drugs without a REMS will not require prescriber and patient registries or REMS data exchange but may have many of the same monitoring requirements. Internal metrics. Measurement is a critical part of assuring quality. KP-SP has developed internal metrics for medication adherence, service performance, quality assurance, and other focus areas. These metrics are used both to assess performance and to identify opportunities for improvements. Data exchange performance is an internal indicator of performance quality. REMS programs may require data exchange (e.g., daily feeds of data from KP-SP to a REMS hub) to ensure compliance for each prescription. Rapid and complete implementation of the data transfer component has been achieved routinely for new products introduced into the KP-SP purview. This is another result of SPIMS, which manages all data related to KP-SP processes and facilitates data exchange functions. Data exchange metrics have shown high rates (e.g., greater than 97%) for data file transmissions within predefined schedules.
Customer surveys. Satisfaction surveys are periodically sent to members for many areas of KP health care services. Based on member comments for KP-SP in surveys, the ability to communicate easily with the KP-SP pharmacist is an important satisfier for members receiving specialty drugs. Members have consistently rated KP-SP service with "Very Satisfied" scores at a level greater than 99% in annual member surveys. Survey response rates have been around 50%. 25 Such metrics and results will vary among the different drugs, criteria, REMS requirements, or other factors. The primary concern is to set criteria, establish goals, and then measure performance.

■■ Conclusions
The integrated health care delivery system and EHR at KP enable the internal SP staff to coordinate the provision of specialty drugs, monitor laboratory results, track physician visits and progress notes, and view other relevant elements of care for the KP member. Direct connectivity to prescribers across all KP regions allows for prompt and efficient resolution of issues, as Top-Index-Tabs: This screenshot in the view for the Kaiser Permanente Specialty Pharmacy (KP-SP) is set on the "Clinical Record" tab. Other major index tabs navigate to information about the prescription, the provider (prescriber), patient counseling, and shipping. Sub-Index-Tabs: Under "Clinical Record," the "Lab" tab is selected and test results are displayed in the columns, with out-of-range results highlighted. (Reference ranges are also presented but not shown here.) Drug-Focused Labs: Specific to a given drug, specific labs are preprogrammed to appear at the bottom of the screen. For this example, drug, liver function, hemoglobin, and hematocrit are the drug-focused labs. The ALT result for March 5th is shown in the lower left, displayed in gray font to highlight that it is out of the reference range. The pharmacist gathers information to assist in assessment of adherence and consultation with the patient. An organized view of all relevant dates helps to plan refills or partial refills and to assess regimen compliance.
• If a patient has missed doses, the pharmacist explores the situation with the patient and suggests strategies. Memory techniques can help some patients who forget to take doses. If adverse events (AEs) are a cause for nonadherence, details are discussed with the patient. The pharmacist and patient decide if the prescriber should be consulted regarding the AEs. • As regards refill planning, the specialty pharmacy staff checks the patient's scheduled appointments versus anticipated refill dates. If needed, partial supplies are provided until after the visit with the prescriber, since dosing could be altered at the time of that appointment with the prescriber.

FIGURE 4
Logistics Planning and Adherence Promotion Screen in SPIMS Key: "Auto Set" is the default setting for the next anticipated refill, calculated by the Specialty Pharmacy Information System (SPIMS) from supply information. This date can be adjusted by the specialty pharmacy staff. The term "auto queue to P-list" is a setting allowing SPIMS to automatically calculate a date 7 days prior to the next anticipated refill, place a task in the "P-list" queue for that date, and then remind the pharmacist to call the patient to discuss adherence issues such as onhand supply, problems with regimen compliance, and other counseling issues. The "P-list" is the "perpetuation list" for pharmacists to contact patients for promotion of adherence.
well as coordination of treatment plans. The KP-SP pharmacist directly counsels and educates patients, while establishing a dialogue in which adherence issues can be identified and improved; clinical monitoring can be augmented with pharmacist-patient interaction; and benefits and logistics issues can be efficiently addressed. While many health care systems may be substantially different from the KP system, some systems may find instructive elements or opportunities in the KP-SP model. The fully integrated EHR is a feature that many health care systems will adopt in the next decade. In addition, care delivery models may evolve toward more accountable care. The KP-SP experience, learnings, and tools may be applicable for others who are adapting to provide care management for specialty pharmaceuticals. Communication, technology, and planning are the most vital building materials for pharmacists involved in specialty pharmacy operations. Software-assisted clinical services such as SPIMS, coordinated with well-designed ambulatory care procedures, may be a framework around which to build optimal therapy management for specialty pharmaceuticals. As these services grow and change, sharing of information among pharmacists and pharmacy operations can ultimately benefit patients served by SP clinical care services.